The number of gastrointestinal (GI) surgeries has been estimated at 500,000 cases annually in the US and the most dreaded complication after any GI surgery is an anastomotic leak or staple-line failure. In the upper GI tract, the main GI surgeries are the Roux-en-Y gastric bypass and sleeve gastrectomy for treatment of morbid obesity, esophagogastrectomy and gastrectomy for benign or malignant disease, and pancreaticoduodenectomy (Whipple) operation.
The number of gastric bypass, sleeve gastrectomy, esophagogastrectomy, gastrectomy, and Whipple operation in the US is estimated to be 200,000 cases per year. Leaks occur in 1-15% of cases depending on the type of operation. Treatments for leaks are complex including re-operation, drainage, long-term antibiotics, lengthy hospitalization, and are very costly for the healthcare system.
The number of colon and rectal surgeries has been estimated between 200,000-300,000 per year in the U.S. for treatment of both benign and malignant disease of the colon and rectum. Rectal and colon resections with a low anastomosis can be associated with high risk for anastomotic dehiscence, leaks, and intra-abdominal abscesses. Despite attention to technical details including construction of a tension-free anastomosis with good blood supply, anastomotic leaks after colon surgery can range between 3-5% and leaks after rectal surgery can range between 10-15% and associated with major morbidities and even mortality. Additionally, anastomotic leak after colon or rectal resection for cancer may be associated with a lower 5-year survival. Treatments for leaks are complex including re-operation, drainage, diversion of the intestine (if not done already), long-term antibiotics, lengthy hospitalization, and are very costly for the healthcare system.
In response to the high risk for anastomotic leaks after rectal surgery, most surgeons perform a prophylactic diverting ileostomy to divert the fecal stream away from the newly constructed rectal anastomosis; however, a diverting ileostomy can be associated with its own risk of morbidities. In addition, the ileostomy will need to be taken down by another operation several weeks after the primary operation which can also be associated with additional morbidity, in addition to the patient's discomfort and pain associated with a second surgery. At the current time, the only prophylactic method to minimize anastomotic leak is surgery by construction of a diverting ileostomy. Despite the use of a prophylactic ileostomy, the leak rate after rectal surgery has not reduced tremendously; however, the severity of the leaks has improved.
Currently, there are no FDA approved indications for prophylactic placement of a protective device after esophageal, gastric, colon and rectal, or pancreatic surgery and there are no available devices on the market. The currently available endoluminal stents on the market are indicated only for relief of obstruction from gastrointestinal malignancy. Therefore, these stents are not optimal in a setting where there are no obstructions and their configurations were not constructed specifically to best protect an anastomosis.
Such conventional methods and systems have generally been considered satisfactory for their intended purpose of treating obstructions within the GI tract. However, there is still a need in the art for a device that can be placed at the time of GI surgery to allow for improved reduction of complications and leaks that develop after colon, rectal, gastric, pancreatic, and esophageal surgeries while minimizing migration of the device through the lumen. There also remains a need in the art for such a prophylactic removable device that is easy to make and use. The present invention provides a solution for these problems.